The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.
Wiling to have one teaspoon (5 ml) of blood drawn.
Willing to have electrodes placed in the external ear.
Diagnosed with gastroparesis for twelve months or longer
Diagnosed with diabetes either Type 1 or Type 2
Unable to provide consent
Pregnant females
Medical records indicate intestinal pseudo-obstruction
Diagnosed with cardiac arrhythmia
Parallel
PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION
DeviceThe IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.
Sham percutaneous electrical nerve field stimulation
DeviceSHAM (no electrical charge)
Change in Gastroparesis Cardinal Symptom Index Daily Dairy
A modified version of the GASTROPARESIS CARDINAL SYMPTOM INDEX - DAILY DIARY (GCSI-DD) will be used. The questionnaire evaluates 4 gastroparesis symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain) and asks participants to rate the severity of symptoms over the past 24 hours on a scale from 0 (none) to 4 (very severe). Additionally, vomiting episodes are reported (0 for none, 1 for one episode, 2 for two episodes, 3 for three episodes, or 4 for four or more episodes). Lower total scores indicate fewer or less severe symptoms.
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms
Scores are calculated by averaging the scores for each item in the subscale, with scores ranging from 0 (none or absent) to 5 (very severe). Optimal outcome would be a score of zero, no episodes/symptoms.
Change in Heart Rate Variability
Heart Rate Variability is reported on a 0-100 scale.
Change in Anxiety
The General Anxiety Disorder (GAD)-7 scale is from 0-21, where 0= no anxiety and 21=severe anxiety
Change in the measure of depression
Patient Health Questionnaire (PHQ)-8 is a questionnaire that measures self-reported depressive systems. PHQ-8 uses a range from 0-24, where 0=no depressive symptoms and 24=severe symptoms.
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms by Diabetes Type
Scores are calculated by averaging the scores for each item in the subscale, with scores ranging from 0 (none or absent) to 5 (very severe). Optimal outcome would be a score of zero, no episodes/symptoms.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
